Newly combined with Baxalta, Shire is now the leading global biotechnology company focused on serving people affected by rare diseases and highly specialized conditions. These diseases are often misunderstood, undiagnosed and life-threatening. Our 22,000 employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
At Shire, we are dedicated to expanding, building and sustaining leadership across our key therapeutic areas through our extensive portfolio of products, innovative pipeline and collaborative approach to working with diverse partners around the globe. We strive to earn and keep the trust of our patients, their families and physicians, and all others who support and advance their care. Working together, the possibilities for our patients, healthcare partners and employees are unprecedented, with significant growth potential for our shareholders.
•Providing leadership and management within CD to provide scientific and clinical development support for products within assigned therapy area.
•Support development and execution of medical & clinical strategy for assigned Shire product(s).
•Preparation of clinical output summary reports, Power Point presentations of the clinical data, clinical trial synopses, patient profiles
•Provides clinical scientist input into all regulatory questions, runs ad hoc searches
•Preparation of targeted reviews/profile of outliers, search and summarize information relevant for various clinical documents preparation
•Act on behalf of Medical Monitor (GCDL) leading the interpretation of trial data and development and review of clinical study documents, reports etc,
•Support GDL/GCDL to provide scientific leadership in execution of clinical trials
•Provide relevant clinical scientist expertise to internal teams, including clinical operations, medical writing, data management, pharmacovigilance to ensure quality processes and deliverables
•Serve as a resource to address medical questions or clarify issues arising during conduct of the study
•Participation/contribution to cross-functional team meetings; Provide support or act as senior company representative interacting with external scientific leaders and/or Regulatory authorities.
•Assists Business Development with assessments and intelligence on potential new products and assists with due diligence activities as required.
•Assist in the review, analysis and reporting of clinical trial data
•Assist with ongoing monitoring of safety data and regular medical review of clinical trial data.
•Serve as a scientific resource to cross-functional internal teams to facilitate quality of study execution and problem resolution
•This position may be combined with the GCDL position when the program is limited in its scope and complexity
•Collaborates with Global Development Lead, Therapeutic Area Head, Business Unit Leaders, Clinical Operations, and Global Medical Affairs to ensure that all development and product support activities for the therapeutic area(s) are coordinated and consistent; Provides scientific advice within Shire R&D and other functions (e.g. Business Unit Strategy Teams, Commercial Brand Teams) leveraging scientific and clinical development expertise and providing guidance in support of brands and product launches.
•Interacts as needed with CD partners such as Clinical Operations, Regulatory, Commercial, Compliance, and Business Unit management teams.
•Leads and/or participates in marketing and clinical/medical advisory panels, steering committees and investigator meetings.
•Assures conduction of appropriate steps to support Therapy Area Business Unit and Commercial Teams in crafting target product profiles.
•May supervises a variable number of CD professional and administrative staff;; Responsible for the overall direction, coordination and evaluation of the direct reports; Responsibilities include interviewing, hiring and training employees, planning assigning and directing work; appraising performance rewarding and disciplining employees, addressing complaints and resolving problems.
•Remains up-to-date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities.
• Provides expert scientific clinical development advice leadership to the project teams for the development of Phase I-IV clinical programs.
•Leads development of clinical studies and reviews clinical protocols and clinical study reports for scientific and operational accuracy.
•Participates in drug safety surveillance for Development projects.
•Develop and demonstrate expertise in data review and interpretation to deliver meaningful efficacy and safety conclusions.
•Demonstrate the ability to interpret conclusions in context of product profiles and medical practice to create key messages, in collaboration with key stakeholders.
•Masters or PhD (preferred) degree is required. Scientific/healthcare field preferred but not required.
•Significant experience (5+ years) of clinical research and organizational management within the pharmaceutical industry, a CRO, an academic research program or similar organization is required.
•Demonstrated ability to collaborate in a matrix environment.
•Experience in submissions of IND/CTX/NDA/MAA and interactions with Regulatory authorities.
•Experience in designing and conducting Phase I-III clinical trials; and/or
•Significant late-stage development research.
•Expertise in hematology preferred
•Experience in rare diseases highly desired
•Demonstrated in-depth understanding of drug development and pharmaceutical marketing within Therapeutic area.
•Working knowledge of regulations relating to drug development and promotional activities.
•Demonstrated ability to communicate and plan effectively with other Shire departments and to respond to inquiries or complaints from customers.
•Demonstrated ability to effectively present information to senior management, employees at all levels of the organization, and external audiences.
•Management skills with demonstrated ability to plan for staffing needs, make hiring decisions, set goals and objectives, establish and recalibrate priorities, provide feedback and appraise work preferred.
•Ability to create and maintain and organizational structure that serves the needs of the business.
•Demonstrated ability to work cooperatively within and outside the organization to accomplish the best outcomes for Shire; ability to build and support teams of diverse background to improve service to present and future customers and to deliver business results.
•Strong judgement and decision-making skills with the ability to understand how decisions fit into the broader context of corporate strategies; demonstrated ability to take a big-picture approach to decision making while taking account of the interests of the entire organization.
•Strong business acumen preferred with the ability to shape corporate strategy using knowledge of the global pharmaceutical industry.
•Ability to capitalize on business opportunities by developing well thought out strategies and initiatives.
•Requires ability to resolve interpersonal issues and motivate individuals and teams towards achieving results. Requires ability to critically assess processes, identify opportunities and implement improvements while collaborating with other functional experts. Requires high degree of problem solving ability; understanding of objectives and processes across multiple organizational functions.
•Availability to travel approximately 25% of time.
•Availability to participate in early or late meetings/teleconferences.
Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
EEO is the law - Supplement
Pay Transparency Policy
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.